The Medical Devices Introductory Course 2020

Clinical Investigation Notification (MDR)

• Notification applications using electronic format (Article 73, not yet set up) submitted to the relevant CA in Member State(s) where the investigation is conducted (usually a fee) • Within 10 days receive acknowledgement (if complete) • Changes must be notified within 1 week of change • 10 (-20) days to respond if CA finds it out of MDR scope or incomplete • CA has 5 days to accept response (if in scope / complete) • Application then considered to be validated - investigation can start at a variable time after validation date: • immediately for Class I, non-invasive IIa and IIb • 45 (- 65) days after validation for others • Ethics Committee approval also required in each Member State prior to start • Documentation required in the submission identified in MDR Annex XV Chapter II (administrative, IB, CIP and related items)

Process outlined in Article 70 of MDR

The Organisation for Professionals in Regulatory Affairs

MDCG and Other Guidance: Clinical Investigations

Title

Reference

Publication

Guidance on safety reporting in clinical investigations

MDCG 2020-10/1

May 2020

Appendix: Clinical Investigation Summary Safety Report Form v1.0 Clinical Investigation

MDCG 2020-10/2

May 2020

IMDRF MDCE WG/N57FINAL:2019

Oct 2019

The Organisation for Professionals in Regulatory Affairs